PHILIPS ANGIOPRO RELEASE 2.1

System, X-ray, Fluoroscopic, Image-intensified

PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Angiopro Release 2.1.

Pre-market Notification Details

Device IDK933791
510k NumberK933791
Device Name:PHILIPS ANGIOPRO RELEASE 2.1
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
ContactWilliam G Mcmahon
CorrespondentWilliam G Mcmahon
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton,  CT  06484
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-04
Decision Date1993-11-22

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